Merck pays $1bn penalty in relation to promotion of rofecoxib

BMJ 2011; 343 doi: (Published 28 November 2011) Cite this as: BMJ 2011;343:d7702
  1. Janice Hopkins Tanne
  1. 1New York

The international drug firm Merck agreed with the US Department of Justice on 22 November to pay $950m (£615m; €720m) to resolve criminal and civil charges over the promotion and marketing of its painkiller rofecoxib (Vioxx).

In 2007 Merck paid $4.85bn to settle about 26 000 lawsuits relating to the drug in state and federal courts (BMJ 2007;335:1011, doi:10.1136/bmj.39398.517176.DB).

The recent fines relate to a long Justice Department investigation of Merck’s promotion of rofecoxib. The funds will go to the US government and to the Medicaid federal insurance scheme for poor people, which paid for the drug under its programmes. Merck did not admit liability or wrongdoing but entered a corporate integrity agreement to strengthen the company’s policies on interactions with health professionals

Bruce Kuhlik, executive vice president and general counsel for Merck, said in a statement, “We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx.”

The federal prosecutor Carmen Ortiz said in a statement, “Today’s resolution appropriately reflects the severity of Merck’s conduct and is yet another reminder that the government will not tolerate misconduct by drug companies that bend the rules and put patient safety at risk. Any marketing activity that ignores the importance of FDA [Food and Drug Administration] approval or that makes unsupported safety claims about a drug is unacceptable and will be pursued vigorously in both the criminal and civil arena.”

Rofecoxib, a cyclo-oxygenase 2 inhibitor, was approved by the FDA in May 1999 for the relief of acute pain, osteoarthritis, and dysmenorrhoea. The drug was heavily promoted by Merck as safer than non-steroidal anti-inflammatory drugs (BMJ 2001:323;767, doi:10.1136/bmj.323.7316.767a).

Questions soon arose over the safety of the drug and its promotion by Merck. In 2001 the FDA criticised Merck for downplaying the risk of stroke associated with rofecoxib and for minimising possible interactions with warfarin (BMJ 2001:323;767, doi:10.1136/bmj.323.7316.767a).

The risk of stroke showed up in a large study called the Vioxx gastrointestinal outcomes research (VIGOR) study, published in the New England Journal of Medicine in 2000 (2000;343:1520-8, doi:10.1056/NEJM200011233432103). The study followed patients taking rofecoxib or naproxen for nine months and found that patients taking rofecoxib had a lower risk of serious gastrointestinal events. However, Eric Topol, a cardiologist at the Cleveland Clinic in Ohio, analysed the data from VIGOR and found that patients taking rofecoxib had a higher relative risk of serious cardiovascular events (JAMA 2001;286:954-9, doi:10.1001/jama.286.8.954).

People who had taken rofecoxib and had cardiovascular damage (or their surviving family members) filed many lawsuits against Merck. Studies showed that the drug might cause heart attacks in the first few weeks of use (BMJ 2006;332:1114, doi:10.1136/bmj.332.7550.1114).

Merck voluntarily took rofecoxib off the market on 30 September 2004 after research showed that it almost doubled the risk of myocardial infarction and stroke when taken for 18 months or longer (BMJ 2004;329:816, doi:10.1136/bmj.329.7470.816-a).

In February 2005 an FDA panel warned that cyclo-oxygenase-2 inhibitors increased the risk of heart attack and stroke and recommended “black box” warnings, the most serious warnings, on drug labelling.

In May 2005 Raymond Gilmartin, the chief executive officer and chairman of Merck, resigned after a report highly critical of the company was released by the US Congress (BMJ 2005;330:1101, doi:10.1136/bmj.330.7500.1101-a). Merck’s official position was that Mr Gilmartin’s resignation ahead of schedule was not related to the Congressional report.


Cite this as: BMJ 2011;343:d7702